View clinical trials related to Diabetic Neuropathy, Painful.
Filter by:The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.
This study aimed to investigate the influence of the glycemic control of type 2 diabetes (DM2) and of cetirizine (OCTs inhibitor) on gabapentin kinetics disposition and pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus, non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=9) and patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in pain visual analog scale (0-10) were investigated.
The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy. A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received IP treatment, whereas 7 participants did not receive IP treatment. Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants Randomization were stratified by current use of gabapentin and/or pregabalin.
The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)
A combined Phase 1 & 2 study to evaluate the safety and effectiveness of a new diabetic neuropathy topical cream, containing benfotiamine, will be performed at 5 clinical sites and plans for BC-DN-01 administration in up to 135 volunteer patients using a standard Phase 1 + 2 design. Up to 15 subjects will receive BC-DN-01 in Study Phase 1 and up to 120 subjects will receive BC-DN-01 or placebo in Study Phase 2. In Phase 1, a BC-DN-01 dose delivering 160mg benfotiamine/day (80mg twice daily) will be administered for the first 7 days. On visit day 0, patients will commence study treatment. Patients will be interviewed by phone on day 3 and return to clinic on day 7 for safety assessments. If the drug is well-tolerated and no significant adverse events experienced, the total daily BC-DN-01 dose will be increased on days 7-14 to 320mg benfotiamine/day (160mg b.i.d.). Patients will be interviewed by telephone on day 10 and return to clinic on day 14 for safety assessments. Once the safety profile has been determined in Phase 1 as acceptable, the Phase 2 study will be initiated to evaluate clinical efficacy of BC-DN-01. Phase 2 is a randomized, placebo-controlled, double-blind, parallel study. Participants receive placebo or BC-DN-01 based on 1:1 randomization. Each patient will apply 4g of the study medication to each leg twice-a-day administering 320mg benfotiamine dose/day for 12 weeks. Participants will be evaluated in the clinic at baseline and at 4, 8, and 12-week time points; study staff will interview the patients by telephone on weeks 2, 6, and 10. The primary endpoint of the phase 2 trial is reduction in DPN pain measured by the Brief Pain Inventory. Phase 2 patients will be invited to give written consent to take part in biopsy sampling and additional gene expression analysis.
Aim of this study is to evaluate safety and efficacy of transcutaneous frequency modulated electromagnetic neural stimulation (FREMS) to treat symptomatic peripheral neuropathy in patients with diabetes mellitus.
The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy. This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
The purpose of this study is to assess the safety and the preliminary efficacy of treatment by the VascuActive device on peripheral diabetic neuropathy, and to correlate this effect with physiologic changes. Patients will undergo a 4-week period of home treatment by the VascuActive device, and will be monitored during this period and during a two-month follow-up period for the efficacy of the device in reducing neuropathic pain, sensation impairment and other signs and symptoms.
The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.